SK-600Ⅱ

Infusion Pump

Operator’s Manual
© 2011-2014 Shenzhen Shenke Medical Instrument Technical Development Co., Ltd.
All rights reserved.

The issue date for this Operator’s Manual is August 2014.

Version: 2.0

I
Intellectual Property Statement

SHENZHEN SHENKE MEDICAL INSTRUMENT TECHNICAL DEVELOPMENT CO.,

LTD (hereinafter called SK Medical) owns the intellectual property rights to this SK
product and this manual. This manual may refer to information protected by copyright or
patents and does not convey any license under the patent rights or copyright of SK
Medical, or of others.
SK Medical intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the
written permission of SK Medical is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any

other derivative work of this manual in any manner whatsoever without the written
permission of SK Medical is strictly forbidden.

, and are the trademarks, registered or otherwise,

of SK Medical in China and other countries. All other trademarks that appear in this
manual are used for informational or editorial purposes only. They are the property of
their respective owners.

II
Responsibility of the Manufacturer

SK Medical reserves the final interpretation for this Operator’s Manual.

SK Medical reserves the right to modify the Operator’s Manual without further notice.
The modified parts will be present in the new edition of Operator’s Manual.

SK Medical is not responsible for any software and devices supplied by companies
other than SK Medical or supplied by distributors.

SK Medical is responsible for the safety, reliability and performance of the product on
condition that all the following conditions are satisfied:

 Installation, expansion, readjustment, improvement and maintenance must be

conducted by professionals authorised by SK Medical.
 All maintenance involving replacement of spare parts, accessories and
consumables should use the original sets or sets authorised by SK Medical.
 Relevant electrical equipment meets national standards and the requirements of
this Operator’s Manual.
 Please operate the product as per the Operator’s Manual.

WARNING
 The device must be operated by professional clinicians or under the
guidance of professional clinicians. The users must receive adequate product
training. No unauthorised or untrained personnel should carry out any
operation.

III
Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions
SK Medical's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential damages
or delay resulting from the improper use or application of the product or the use of parts
or accessories not approved by SK Medical or repairs by people other than SK Medical
authorised personnel.

This warranty shall not extend to:

 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified or
unauthorised service people.
 Malfunction of an instrument or part whose serial number is not fully legible.
 Other malfunctions not caused by an instrument or part itself.

IV
Company Contact

Manufacturer: Shenzhen Shenke Medical Instrument Technical

Development Co., Ltd
Address: Floor 2, 3, 4, Building 1, Section 1, Baiwangxin Hi-Tech
Industrial Park, Songbai Road, Xili, Nanshan, Shenzhen
518108, P.R. China
Website http://www.skmedica.com
Service Hotline: +86 400 700 5652
Tel: +86 755 82402696
Fax: +86 755 82438567

EC-Representative: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestrasse 80, 20537 Hamburg，Germany

Tel: +49-40-2513175
Fax: +49-40-255726

V
Preface

Purpose of the Manual

This Operator’s Manual describes the product’s application, function and operation in
detail. Please read this Operator’s Manual carefully and understand the content before
use, in order to ensure the proper usage and guarantee the safety of the patient and the
user.
This Operator’s Manual describes the product as per the most complete configuration.
Some content of this manual may not be applicable for the product you are handling.
Please contact us if you have any questions.
Please store this Operator’s Manual with the infusion pump in order to consult it at your
convenience.

Intended Audience
This Operator’s Manual is only applicable to use by suitably qualified clinicians.

Illustrations
All illustrations in this Operator’s Manual are used for reference only. Settings or data
shown may not be entirely consistent with the actual information displayed on the
product.

Conventions
 Italic text is used in this manual to quote referenced chapters or sections.
 The terms “Danger”, ”Warning”, and “Caution” are used throughout this manual
to point out hazards and to designate a degree or level of severity.

VI
Contents
1 Safety .................................................................................................................. 1-1
1.1 Safety Information ............................................................................................. 1-1
1.1.1 Dangers ................................................................................................ 1-2
1.1.2 Warning ................................................................................................. 1-2
1.1.3 Caution.................................................................................................. 1-4
1.1.4 Note ...................................................................................................... 1-5
1.2 Labels and Symbols .......................................................................................... 1-6
1.2.1 Equipment Symbols .............................................................................. 1-6

2 Overview ............................................................................................................. 2-1

2.1 Product Description ........................................................................................... 2-1
2.1.1 Indications for Use ................................................................................ 2-1
2.1.2 Contraindications .................................................................................. 2-1
2.1.3 Product Appearance, Parts and Features ............................................. 2-2
2.2 Product Exterior ................................................................................................ 2-3
2.2.1 Front View ............................................................................................. 2-3
2.2.2 Rear View ............................................................................................. 2-6
2.3 Screen Display .................................................................................................. 2-7
2.4 Battery .............................................................................................................. 2-8
2.4.1 Description ............................................................................................ 2-8
2.4.2 Battery Guidelines ................................................................................. 2-8
2.4.3 Battery Maintenance ............................................................................. 2-9
2.4.3.1 Battery Optimization ..................................................................... 2-9
2.4.3.2 Checking the Battery .................................................................. 2-10
2.4.4 Battery Recycling ................................................................................ 2-10

3 Installation and Maintenance ............................................................................ 3-1

3.1 Installation ......................................................................................................... 3-1
3.1.1 Out of Box Audit (OOBA) ...................................................................... 3-1
3.1.2 Operating Conditions ............................................................................ 3-2
3.1.3 Power Supply Requirements ................................................................. 3-2
3.1.4 Fixing the Infusion Pump....................................................................... 3-3
3.1.5 Installing the Power Cord ...................................................................... 3-4
3.1.6 Installing the Drop Sensor (optional) ..................................................... 3-4
3.2 Maintenance ..................................................................................................... 3-6
3.2.1 Inspection .............................................................................................. 3-6
3.2.2 Cleaning and Disinfection ..................................................................... 3-7
3.2.3 Periodic Maintenance............................................................................ 3-9
3.2.4 Safe Disposal and Recycling ................................................................ 3-9

1
4 Operation Guide ................................................................................................. 4-1
4.1 Operation Flow Chart ........................................................................................ 4-1
4.2 Operating Instructions ....................................................................................... 4-2
4.2.1 Turning on the Pump ............................................................................. 4-2
4.2.2 Installing the Infusion Tube ................................................................... 4-3
4.2.3 Setting Parameters ............................................................................... 4-4
4.2.4 Zeroing the Volume ............................................................................... 4-5
4.2.5 Starting the Infusion .............................................................................. 4-6
4.2.6 Infusion Finished ................................................................................... 4-6
4.2.7 Turning off the Pump ............................................................................. 4-6

5 Functions and Screens ..................................................................................... 5-1

5.1 Infusion mode ................................................................................................... 5-1
5.2 Advance Setting ................................................................................................ 5-3
5.2.1 Bolus Function ...................................................................................... 5-5
5.2.1.1 Auto Bolus Function ...................................................................... 5-5
5.2.1.2 Manual Bolus Function ................................................................. 5-6
5.2.1.3 Manual Bolus Infusion Settings..................................................... 5-6
5.2.2 Drop Rate Function and Setting (Optional) ........................................... 5-7
5.2.2.1 Starting the Drop Rate Function.................................................... 5-7
5.2.2.2 Setting the Drop Rate for the Infusion Tube .................................. 5-8
5.2.2.3 Viewing the Drop Rate screen ...................................................... 5-9
5.2.3 Using a Different Brand of Tube ............................................................ 5-9
5.2.3.1 Accuracy Calibration ................................................................... 5-10
5.2.3.2 Pressure Adjust........................................................................... 5-10
5.2.4 Occlusion Level Settings ..................................................................... 5-12
5.2.5 AirLevel Settings ................................................................................. 5-12
5.2.6 Reminder Settings............................................................................... 5-13
5.2.7 Locktime Settings ................................................................................ 5-14
5.2.8 Audio Volume ...................................................................................... 5-15
5.2.9 Language Options ............................................................................... 5-15
5.2.10 Record .............................................................................................. 5-16
5.3 Purge .............................................................................................................. 5-16
5.4 Changing the Rate during Operation .............................................................. 5-17
5.5 Automatic Pressure Release Function (Anti-Bolus) ........................................ 5-18
5.6 Memory Function ............................................................................................ 5-18
5.7 Drug Library .................................................................................................... 5-19

6 Alarms ................................................................................................................. 6-1

6.1 Description ........................................................................................................ 6-1
6.2 Alarm level ........................................................................................................ 6-1
6.3 Alarm types ....................................................................................................... 6-1
6.3.1 Visible alarms ........................................................................................ 6-2
6.3.2 Audible alarm ........................................................................................ 6-2

2
 6.3.3 Alarm Information .................................................................................. 6-2
6.4 Alarm Countermeasures ................................................................................... 6-3

A Product Specifications ..................................................................................... A-1

A.1 Safety Specifications ........................................................................................ A-1
A.2 Operating Environment ..................................................................................... A-1
A.3 Power Supply ................................................................................................... A-2
A.4 Hardware Specifications ................................................................................... A-2
A.5 Auditory Indicator .............................................................................................. A-3
A.6 Basic Infusion Pump Parameters ..................................................................... A-3
A.7 Occlusion Alarm Pressures, Delays for Alarm Times and Maximum Permissible
Dose Volumes ......................................................................................................... A-5
A.8 Infusion Accuracy Table .................................................................................... A-6
A.8.1 Accuracy Curve .................................................................................... A-6
A.8.2 Bell-shaped Curve ................................................................................ A-7

B EMC and Radio Regulatory Compliance ........................................................ B-1

B.1 EMC ................................................................................................................. B-1
B.2 Radio Regulatory Compliance .......................................................................... B-6

C Alarm Information............................................................................................. C-1

C.1 Alarm Information ............................................................................................ C-1
C.2 Prompt Messages ........................................................................................... C-4

D Symbols and Terms.......................................................................................... D-1

D.1 List of Units...................................................................................................... D-1
D.2 List of Terms .................................................................................................... D-2

3
FOR YOUR NOTES

4
1 Safety
1.1 Safety Information
The safety statements presented in this chapter refer to basic safety information that
the operator must pay attention to and abide by when using the infusion pump.There
are additional safety statements in other chapters or sections, which may be the
same as or similar to the following, or specific to particular operations.

Dangers
 Indicates an imminent hazard that, if not avoided, could result in death,
serious injury or damage to product/property.

WARNING
 Indicates a potential hazard or unsafe practice that, if not avoided, could
result in death, serious injury or damage to product/property.

CAUTION
 Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury, product malfunction or damage to
product/property.

NOTE
 Provides application tips or other useful information to ensure that you
get the most out of the product.

1-1
1.1.1 Dangers

Dangers
 The infusion tube must be installed straight and level in the bottom of
the groove on the infusion pump.

1.1.2 Warning

WARNING
 This infusion pump is used for clinical infusion. It can only be used by
professional clinicians, medical electrical experts, or suitably trained
nurses on specific occasions.
 The infusion pump and its accessories must be inspected before use to
guarantee their normal and safe operation.
 Avoid using this infusion pump in a flammable or explosive atmosphere
in case of fire outbreak or explosion.
 Alarm levels must be set at levels appropriate to the patient's clinical
condition.Do not rely too heavily on the audible alarm system during
infusion supervision. Pay close attention to the actual clinical situation
of the patient.
 Keep monitoring the remaining liquid volume in the infusion bags (or
infusion bottles) and check that there are no air bubbles in the infusion
tubes during the infusion. Do not rely solely on the alarm function of the
infusion pump.
 The pressure sensor may not work normally in high-pressure
environments, for example during hyperbaric oxygen therapy.
 Make sure the blood vessel is well protected before infusion.
 Infusion tube knots, filter coagulation and occlusions arising from
needle insertion can cause the pressure inside the infusion tube to
rise.If this occurs, the effort to eliminate the occlusion may cause an
excessive dose of liquid to be infused into the patient’s
body.Appropriate measures should be taken to prevent overdose.For
example,the infusion tube should be clamped before eliminating the
occlusion.
 This infusion pump should be used 120 cm above or below the patient’s
heart.

1-2
 Avoid using the infusion pump when an alarm is sounding.
 When another set of infusion systems or accessories is connected to
the infusion tube used in this infusion pump, the operation of this pump
may not meet its specifications.
 Only standard components, connectors and disposable products can be
used with this pump.Subsidiary items must not be attached to the pump
and its accessories. Modification of the pump is prohibited and may lead
to unexpected consequences.
 The pump's accuracy will not be maintained when it is used with a
non-standard infusion tube or the parameters of the infusion tube are
not set accurately. The maximum deviation may reach 40% or above.
 Disposable accessories must be disposed of after use in accordance
with the relevant hospital regulations.
 This infusion pump belongs to Class II (type of electric shock
protection); the supplied Type I power cord PE earth terminal should not
be used as ground protection and functional earthing.
 Do not open the casing of the infusion pump, as you may suffer an
electric shock.The infusion pump must be maintained or updated by
maintenance staff trained and authorized by our company.
 The packaging materials must be disposed of in compliance with local
laws and regulations or the hospital policy on waste management.They
must be kept out of the reach of children.
 The double thickness of the infusion tube should be between 0.8
mm–1.2 mm. The outer diameter should be between 3.5 mm–4.5 mm.
Otherwise, its accuracy cannot be guaranteed, and may cause serious
injury to patients.

1-3
1.1.3 Caution

CAUTION
 Please use the accessories specified in this Operator’s Manual to
guarantee the patient’s safety.
 Cables must be connected carefully to reduce the possibility of the
patient choking or getting caught in them.
 Disposable accessories must be used once only. Repeated use may lead
to deterioration in performance or cross-infection.
 After installation of the infusion tube and before infusion, check for
leakages. If any are found, they should be rectified as soon as possible.
 Adjust the fixing site of the infusion tube every 4 hours after infusion
begins, in order to guarantee its accuracy.Replace the infusion tube
after the infusion has been running for 24 hours.
 When this infusion pump and its accessories exceed their service life,
they must be disposed of in accordance with local statutes or hospital
regulations.If you have any queries, please contact your distributor or
the manufacturer.
 Electromagnetic fields may influence the performance of the infusion
pump. Therefore, equipment or devices used in the vicinity of the
infusion pump must meet the EMC standard.Mobile phones, X ray and
MRI equipment are all potential interference sources because of their
high-intensity electromagnetic radiation.
 Avoid direct sunshine, high temperatures and humidity.
 Avoid exposing this infusion pump to high-pressure sterilization or
chemical materials.
 Check the built-in battery before use to make sure it has sufficient
power.Recharge the battery if necessary.
 Before the infusion pump is connected to the power supply, make sure
the voltage and frequency of the power supply comply with the label on
the pump or the specific requirements outlined in this Operator’s
Manual.
 Please install and carry the infusion pump appropriately to protect the
pump from being dropped, knocked, violently shaken, or suffering other
damage caused by forces external to the machine.
 Use a piece of soft cloth dampened with warm water to wipe the surface
of the infusion pump if any liquid is spilled on it.
 If the surface tension, specific gravity and viscosity of the feed solution

1-4
 are different from saline (for example, a solution mixed with surfactant),
the pump accuracy for delivery of solution may be different from the
accuracy listed here.
 When the infusion rate is high (≥ 1000 ml/h), high-quality silicone tubes
with 0.9 mm transfusion needles must be used with the pump in order to
maintain infusion accuracy.
 If the infusion pump fails to work as specified in the Operator’s Manual
and the cause is uncertain, stop the infusion and report the situation
(including infusion accessories used with the pump, infusion volume,
infusion rate, serial number, liquid type, etc.) to your distributor or the
manufacturer.
 The drop sensor is not applicable to light-proof medicine infusions.
Adopting light-proof IV sets on the pumps might cause the drop sensor
to fail and result in serious injury to patients.

1.1.4 Note

NOTE
 Keep this Operator’s Manual near to the infusion pump for ease of future
reference.
 Install the infusion pump where convenient for its supervision, operation
and maintenance.
 This Operator’s Manual describes all the settings and functions of the
infusion pump in its most complete functional configuration. The
infusion pump you are handling may not have some of the settings or
functions described herein.
 Do not insert devices that are not specified by the manufacturer into the
data ports.

1-5
1.2 Labels and Symbols
1.2.1 Equipment Symbols
Refer to Operator's Manual
Class CF device
Alternating current power
supply (AC)
Date of manufacture
Electronic equipment: dispose
of separately to avoid polluting
the environment
Up or increase value
Confirm
Stop
Start
Clear
ON/OFF
Fragile item, handle with care
Maximum stack height without
additional packaging: 5 layers
Packaged product should not
be exposed to pressures
outside the range 50–106 kPa
CE mark product, complies with
EU directive MDD 93/42/EEC
and annex I thereof.
Class II equipment
IP21 Splash-proof
Direct current power supply (DC)
Serial number
Manufacturer
Wireless transceiver
Down or decrease value
Settings
Silence
Bolus
Select
Protect from rain during transport
Keep upright during transport
Packaged product should not be
exposed to humidity outside the
range 10%–95% during transport
Packaged product should not be
exposed to temperatures outside
the range -20–55°C during
transport
1-6
2 Overview
2.1 Product Description
2.1.1 Indications for Use
This infusion pump is for use in wards, operating theaters, and observation rooms for
accurate and continuous infusion to patients.

This infusion pump is expected to be used in institutes or units with healthcare

capabilities, such as hospital outpatient departments, accident and emergency
departments, wards, operating theaters, observation rooms, clinics, nursing homes,
etc.

WARNING
 The infusion pump and its accessories must be inspected before use to
guarantee their normal and safe operation.

CAUTION
 The operating environment and power supply of this infusion pump
must meet the requirements specified in A. Product Specifications.

2.1.2 Contraindications
None

2-1
2.1.3 Product Appearance, Parts and Features
The SK-600Ⅱ Infusion Pump mainly comprises a host computer, internal
rechargeable battery and other parts.

The SK-600Ⅱ Infusion Pump contains the following parts:

 Control System:The core of the whole system. Provides smart control and
management of the whole system and processes sensor signals. The system
employs two single chips which each backup and monitor the other.When one
SCM fails, the other one will give a timely warning signal and cut the power of the
host computer to stop the pump with the purpose of ensuring the patient’s safety.
 Pump:the power source of the infusion, employs a step motor to drive the
continuous extrusion of the pump tablets upon the infusion tube, in order to
achieve infusion.
 Monitoring System:the device mainly includes various types of sensor, including
an air bubble sensor (detects air bubbles inside the infusion tube), a pressure
sensor (detects the pressure inside the infusion tube), etc.
 Alarms:Audible and visible alarms. Attract the user's attention and remind the
user about correct operation of pump.
 Input and Display Systems:The input device is used for setting pump parameters
such as flow rate.The display shows parameters and operational status.
 Battery:the battery sustains the operation of the infusion pump when there is no
AC power supply.

SK-600Ⅱ Infusion Pump Performance:

 Accurate control of flow rate
 Accurate control of volume
 Accurate control of infusion time
 Alarms for Air Bubble, Finish, Occlusion, Battery Empty, System Error, Motor
Error, Drops Error, Low Battery, Tube Error, Parameter Error, Reminder, Handle Open,
AC Disconnect etc.
 Selectable infusion modes, such as Drop Mode (optional), Rate Mode, Time
Mode and Body Weight (BW) Mode.

2-2
2.2 Product Exterior
2.2.1 Front View

1. Alarm indicator lamp

 Flashing red light for high-level alarm;
 Flashing amber light for medium-level alarm;
 Steady amber light for low-level alarm.
2. AC indicator lamp
This light is steady green when the AC power supply is connected.
3. Running indicator light
This light illuminates steady green after the infusion tube is correctly installed, and
flashes during infusion.
4. Quick operating instructions
Guidance for simple processes.
5. Tube fixing groove
Used to secure the infusion tube.
6. Display
Displays infusion program and running status.

2-3
7. Handle
 Pull the handle up:to install or remove the infusion tube.
 Push the handle down:to tightly clamp the tube and prevent the handle from
protruding at the side.If the infusion tube is correctly installed, the running indicator
light will illuminate when the handle is pushed down. Otherwise, reinstall the tube.
8. UP/DOWN keys
 UP key:Move cursor up or increase value.
 DOWN key:Move cursor down or decrease value.
9. OK key
 Enables the value of the selected parameter to be adjusted;
 Confirms the current setting；
 In Run state, press this key to change the rate.
10. STOP key
 During infusion, press this key to stop infusion;when an alarm is sounding, this
key will also silence the alarm (except battery alarms).
 In the Accuracy Calibration and Pressure Adjust screens, cancels current setting
and exits the screen.
11. START/BOLUS key
 In stop status, if the infusion tube is correctly installed, pressing this key starts
infusion.
 In the Run screen, press and releaseto enter the Auto Bolus setting screen. After
setting the parameters, press and release once again to enter Bolus state.
 In the Run screen, press and holdto start Bolus; on release the pump will return
to the original flow rate.
12. SET key
 Switches the infusion mode.
 In the Advanced Setting screen, saves the current setting and exits the screen.
 In the Run screen, press and hold to lock;In locked state, press and hold to
unlock.
13. POWER key
 To turn on the machine:press and release.
 To turn off the machine:press and hold until the progress bar completes, then
release.
14. POWER ON light
Shines steady green when the pump is switched on.

2-4
15. SELECT key
 Used to select the increment/decrement step,which is displayed in the middle of
the screen title bar.
16. CLEAR/SILENCE key
 In the Stop Mode settings screen, press this key to clear the accumulated
volume.
 When entering parameters, use this key to return parameter to its minimum
value.
 When an alarm occurs in the Run screen, press this key to pause the alarm tone
for 2 minutes (except battery alarms).
 In the Auto Bolus screen, press this key to restore the original flow rate.

2-5
2.2.2 Rear View

1. AC power supply port

2. Handle
3. AC power supply label
4. Product label
5. Vent
6. Speaker
7. Fixing clamp
Secures the infusion pump to the stand.
8. Fixing clamp knob
Used in conjunction with the fixing clamp to secure the infusion pump to the stand.
9. Drop sensor port (drop sensor is an optional purchase accessory)

2-6
2.3 Screen Display
This infusion pump has a built-in LCD screen. The display information comprises
three main parts:

1. Title bar
Displays the currently selected infusion mode, increment/decrement step and
infusion tube category.
 Infusion mode:4 modes in total — Rate Mode, Time Mode, BW (Body Weight)
Mode and Drop Mode.
 Increment/decrement step:selectable step values are 0.1, 1, 10, 100 and 1000.
 Infusion tube type:the user-defined infusion tubes A, B, and C represent different
types of infusion tube.
2. Parameter area
Displays all the parameter values for the current mode.
3. Status bar
Displays infusion pump alarm information, pressure status, status icon and power
icon.
 Alarm information:Finish, Occlusion, etc.
 Pressure status:indicates the current pressure of the infusion tube.
 Status icon:displays the current status of the infusion pump. The four possible
statuses are Stop, Run, KVO or Bolus.
 Power icon:
a) When connected to the AC power supply and the battery is fully charged, the
screen shows a power plug;
b) When connected to the AC power supply and the battery is not fully charged,
the screen shows the battery charging icon;
c) When disconnected from the AC power supply, the screen shows the battery
icon and the remaining charge.

2-7
2.4 Battery
2.4.1 Description
This infusion pump uses a built-in rechargeable battery to guarantee the normal use of
the pump during patient transfers or power outages in the hospital.The battery will
automatically charge itself when the pump is connected to the AC power, both in Power
On and Power Off mode.The pump will operate with its battery in the event of a sudden
power failure.
The battery can only provide power for the pump to operate normally for a certain length
of time.Once the battery reaches its minimum charge, the pump will emit an alarm tone
every few seconds and display the words "Low Battery" to notify the user;After a certain
length of time, the pump will emit a rapid beeping alarm tone and display the words
"Battery Empty" with the alarm indicator light flashing. If the pump is running at this time,
it will automatically stop the infusion and will not operate until it is connected to the AC
power.The battery empty alarm will only stop sounding after the pump is connected to
the AC power.
The alarm indicator light and battery icon both indicate the battery's current status:
 When the battery is empty, the red alarm light flashes.
 When the battery is low, the amber alarm light flashes.
 When not connected to the AC power supply, the amber alarm light glows steady.
 When charging, the AC indicator light glows steady amber and the battery
charging icon is displayed in the lower-right corner of the screen.

NOTE
 8-14 hours are required to fully charge an empty battery.
 Please discharge the battery every 3 months to prevent damage to the
battery if the product is not in regular use.
 The battery can be replaced. Please replace it when it no longer holds
adequate charge.
 If you have any queries, please contact the distributor or the
manufacturer.

2.4.2 Battery Guidelines

The lifespan of the battery depends on how frequently it is used and on the
operating environment.If it is used and maintained correctly, its lifespan is 3
years.Its lifespan will be shortened if it is not used correctly.The battery will need to
be replaced every 3 years.

2-8
 For safe use and longer battery life, please adhere to the following battery
guidelines:
 The battery should be checked annually.Before the pump is sent for
maintenance or if you suspect the battery to be the cause of a problem, the battery
should be checked.
 Optimize the battery every 3 months of use (or storage), or once the battery
running time is significantly shortened.

WARNING
 Use the battery specified by the manufacturer.
 Please replace the battery immediately if it is damaged or leaking.
 Damaged batteries must not be used.
 Used batteries must be returned to your supplier or the manufacturer, or
disposed of in accordance with applicable laws and regulations.

2.4.3 Battery Maintenance

2.4.3.1 Battery Optimization
Optimize the battery when it is used for the first time.A complete optimizing cycle
entails the following: charge continuously until the battery is fully charged, then
discharge the battery until the pump powers off automatically, then charge the
battery continuously again until fully charged.During usage, regularly optimizing the
battery performance will extend its lifespan.

NOTE

 The actual battery capacity will reduce after the battery has been used for
some time.If the battery capacity is obviously shortened during optimization,
please replace the battery.

Please follow the steps below during optimization:

1. Disconnect the infusion pump from the patient, and stop the infusion.
2. Connect the infusion pump to the AC power, charging continuously for 12
hours.
3. Disconnect the infusion pump and the AC power, using the battery as the
power supply until the infusion pump powers off automatically.
4. Connect the infusion pump to the AC power, charging continuously for 12
hours.
5. The charge cycle is now complete.

2-9
2.4.3.2 Checking the Battery
Regular battery checks are required because battery function may deteriorate as it
is used.

NOTE
 If the battery only provides power for a short time after being fully
charged, it may be damaged or faulty.The battery’s power supply time
depends on the usage frequency of the pump and its setting parameters.
 If the battery has obvious damage (e.g. misshapen, dented, leaking) or
cannot hold charge, it should be replaced and recycled.

2.4.4 Battery Recycling

If the battery has obvious damage (e.g. misshapen, dented, leaking) or the battery
capacity has deteriorated, it should be replaced and recycled.Please follow the
applicable laws on recycling.

WARNING
 The battery must not be disassembled, burned or
short-circuited.Burning, exploding or leaking batteries can cause
personal injury.

2-10
3 Installation and Maintenance
3.1 Installation

WARNING
 The software copyright of this infusion pump belongs to our company.
Any infringement such as falsification, reproduction or exchange by any
means or in any form by any organization or individual is prohibited
without permission.

3.1.1 Out of Box Audit (OOBA)

Before opening the box, please check the packaging carefully for any damage to the
products during transportation.If there is any damage, please contact the distributor
or manufacturer immediately.

If the packaging is intact, please open it immediately, carefully remove the infusion
pump and its accessories, and inspect them against the packing list.Examine the
pump for any mechanical damage and ensure that the box includes all items on the
packing list.Please contact our customer service department immediately if you have
any queries.

WARNING
 Please keep packaging materials out of the reach of children.The
packaging materials must be disposed of in compliance with local laws
and regulations or the hospital policy on waste management.

NOTE
 Please keep the packing case and packaging materials for future
transport or storage.
 Please contact the distributor or the manufacturer if any of parts are
missing when you open the box.

3-1
3.1.2 Operating Conditions
The operating environment of this infusion pump must meet the requirements in A.2
Environmental Specifications.

The operating environment of this infusion pump should also be appropriately

protected from noise, vibration, dust, and corrosive, inflammable or explosive
substances.There should be a 2-inch (5 cm) gap around the infusion pump to ensure
that air can circulate freely.
When the infusion pump is transferred from one place to another, the difference in
temperature and humidity may cause condensation to form in the infusion pump. If
this is the case, do not switch on the pump until the condensation has gone.

3.1.3 Power Supply Requirements

The power supply for this infusion pump must meet the requirements in A.3 Product
Specifications.

WARNING
 Ensure that the operating environment and power supply meet
environmental requirements and the power supply requirements
specified above. Otherwise, the infusion pump will not meet the
technical specifications outlined in A. Product Specifications, and this
may also cause unexpected consequences such as damage to the
device.
 The power supply must be selected in accordance with the settings for
the system power voltage.Otherwise, it may cause severe damage to the
system.

3-2
3.1.4 Fixing the Infusion Pump

Figure 3-1

Instructions for fixing the infusion pump as shown in Fig. 3-1:

1. Pump stand
2. Fixing clamp knob

Figure 3-2 Figure 3-3

3-3
Procedure for installing infusion pump onto infusion pump stand:
1. As shown in Fig. 3-2, for convenience, rotate the clamp knob counter-clockwise and
make enough room for the installation of the pump on the stand.
2. As shown in Fig. 3-3, place the stand in line with the clamp, and then turn the clamp
knob clockwise until the infusion pump is securely installed on the stand.

NOTE

 The infusion pump must be installed horizontally.

 Please ensure the stand is stable before installation.

3.1.5 Installing the Power Cord

Plug the power cord into the socket on the machine.

NOTE

 Compatible power supply: 100–240 V, 50/60 Hz.

 The AC power cable should be inserted correctly and tightly.

3.1.6 Installing the Drop Sensor (optional)

NOTE
 This section should be used with the optional drop sensor. The user may
skip the instructions in this section if a drop sensor is not included with
the infusion pump.
 The drop sensor function can only be started when the rate ≤ 400 ml/h.
Otherwise, the excessively high drop rate will cause the drop sensor to fail

3-4
 Fig. 3-4 Fig. 3-5

1. Firmly insert the drop sensor power plug into the connecting port on the rear panel; at
the same time, the volume of the liquid in the filter must be less than 1/3 that of the filter
volume.
2. As shown in Fig. 3-5, clip the drop sensor to the liquid filter (by manually applying
pressure as shown in Fig. 3-4), making sure that the drop sensor is above the surface of
the liquid.

NOTE

 The surface of the liquid in the filter must be lower than the drop sensor.
 The positioning block of the filter must be inserted vertically through the
positioning groove on the drop sensor.
 The infusion tube must be replaced once it has operated continuously
for over 24 hours.
 Do not tilt the drop sensor, or expose it to direct sunlight during
infusion.
 Make sure that the medicine liquid filter is not clamped too tightly by the
drop sensor.

3-5
3.2 Maintenance

WARNING
 The hospital or medical facility using this infusion pump must set up a
comprehensive maintenance plan. Failure to do so may result in device
failure or other unexpected consequences, and may even jeopardize
personal safety.
 All safety inspections or maintenance work involving the disassembling
of the pump must be conducted by professional maintenance personnel.
Action by unqualified persons may result in device failure and even
jeopardize personal safety.
 Please contact your distributor or the manufacturer immediately if you
discover any problem with the pump.

3.2.1 Inspection
The pump must be given an overall inspection before use, after it has been in
continuous use for over 6 months, or after maintenance or updating, so as to
ensure that it is operating and functioning normally.

The inspection criteria are:

 The environment and power supply meet requirements
 The infusion pump and accessories have no mechanical damage
 The power cord is not damaged and has sufficient electrical insulation
 Accessories used with the pump are correct
 The alarm system functions correctly
 Battery function is good
 The pump operates well in all infusion modes
 Current leakage meets requirements.

If any pump damage or abnormal circumstances occur, please do not use the
infusion pump, and contact your distributor or the manufacturer immediately.

3-6
3.2.2 Cleaning and Disinfection
The pump must be cleaned or disinfected using the materials and methods listed in
this chapter. Otherwise, our company will not be responsible for any damage or
accident caused by cleaning and disinfection using other materials and methods.

The manufacturer shall not be held responsible for the efficacy of the following
chemicals or methods for infection control.Please contact your hospital's infection
prevention department or epidemiology specialists for advice on infection control
practices.

Please keep the infusion pump and accessories free of dust,and comply with the
following provisions to prevent damage to the pump:
 Dilute all cleaning agents and disinfectants in accordance with the
manufacturer’s instructions, or use as low a concentration as possible.
 Do not submerge the pump in liquid.
 Do not pour liquid onto the device or its accessories.
 Avoid liquid entering the pump body.
 Do not use abrasive materials (such as steel wool or silver polishing agent) or
any strong xylene or acetone-type solvent, in order to prevent damage to the
outer casing.

WARNING
 Turn off the power and disconnect the AC power supply before cleaning
the infusion pump.

CAUTION
 If liquid is accidentally spilled on the infusion pump or its accessories and
causes the infusion pump to stop working, please contact your distributor
or the manufacturer.

The infusion pump should be cleaned regularly. The cleaning frequency should be
increased in areas with serious environmental pollution or in very windy or sandy
areas.Before cleaning, please consult or refer to the hospital's specific regulations
concerning medical device cleaning.

3-7
The recommended cleaning agents and disinfectants are:
 Warm water
 Dilute soapy water
 Dilute aqua ammonia
 Sodium hypochlorite (bleaching powder for washing)
 Hydrogen peroxide (3%)
 Ethanol (70%)
 Isopropanol (70%)

Recommended procedure for cleaning and disinfection:

1. Turn off the power and disconnect the power cord.
2. Use a piece of soft cloth dampened with warm water to wipe the surface of the
infusion pump if any liquid is spilled on it.
3. Wipe the surface of the pump with a soft cloth soaked in 70% ethanol.
4. Keep the pump in a cool and ventilated environment to dry.
The above steps are for reference only. The effects of disinfection should be
checked according to the relevant method.

CAUTION

 Do not use ethylene oxide (EtO) gas or formaldehyde for disinfection.

3-8
3.2.3 Periodic Maintenance
1. Checking the Infusion Flow
Check the infusion flow volume every 3 months using a measuring cylinder and
stopwatch.

WARNING
 Operators should not rely solely on the infusion pump detection
function, but should also use their clinical experience to determine
whether the infusion flow rate is normal.

2. Maintaining battery performance

Refer to 2.4.3 Battery Maintenance.
3. Routine Maintenance

Frequency Routine Maintenance Procedures

According to Thoroughly clean the infusion pump casing before or
hospital policy after long storage periods.
1. Check the AC power plug and power cord.
2. Run the machine until it emits a low battery alarm.
Inspect the pump at Then charge the battery to ensure it works and
least once a year. recharges fully.
3. Check for leakages after correct clamping of the
infusion tube.

3.2.4 Safe Disposal and Recycling

For more information about safe disposal and recycling, please contact the
distributor or the manufacturer.

You can dispose of the pump and accessories as follows:

1. SK-600II Infusion Pumps that are no longer needed can be sent back to your
distributor or the manufacturer for proper recycling.
2. Used batteries can be sent back to your distributor or the manufacturer for
disposal, or disposed of in accordance with applicable laws and regulations.

3-9
FOR YOUR NOTES

3-10
 4 Operation Guide
4.1 Operation Flow Chart
Fill the infusion bags (bottles) with the prepared liquid medicine,
Prepare Infusion remove any air bubbles, and turn off the infusion tube flow rate
regulator.

Turn on the machine

Press the key.

Install the Infusion Set
Set the infusion parameters
1. Open the handle, pull the infusion tube straight and clip it straight and
level into the bottom of the groove on the infusion pump;
2. Gently fold down the handle (make sure that it does not protrude at
the side); the running indicator will illuminate. Turn on the infusion flow
rate regulator.
Set the parameters, referring to 4.2.3 Setting Parameters.

Observe whether there are any residual bubbles in the extension tube.

Check and remove any air If there are, press the key to start the infusion pump. Press the
bubbles
key again and hold it down to rapidly discharge the bubbles from the

infusion tube, then press the key.

Clear the accumulated
amount Press the key.

Connect the patient and the

pump Connect the infusion tube to the patient.

Start Infusion
Press the key.

Infusion Finished Press the key.

Disconnect the infusion tube Make sure that the infusion has stopped, then disconnect the infusion
between patient and the pump tube from the patient and remove the infusion tube.

Turn off the Infusion Pump

Press and hold the key.

4-1
4.2 Operating Instructions

NOTE
 Part of this section covers the Drop Sensor function. If the user needs to
use this function, the drop sensor should be purchased as an accessory to
the infusion pump. For more details, please consult your distributor or the
manufacturer.

4.2.1 Turning on the Pump

After installing the infusion pump, turn on the device by referring to the following
steps:
1. Perform a safety inspection referring to 3.2.1 Inspection before turning on the
pump.

2. Press the key. The pump will start self-checking.

3. After a few seconds, the pump will finish self-checking and enter the Run screen.
4. Now the user can operate the pump by means of the operating panel.

NOTE
 The power plug symbol displayed on the screen indicates that the pump is
running on AC power.

4-2
4.2.2 Installing the Infusion Tube

①Pull out the door lock as shown by the ②Pull the infusion tube straight
arrow

Install the two ends of the infusion tube

into the bottom of the infusion groove

③Install the infusion tube straight and level in ④Push down the handle after installation
the bottom of the groove on the infusion
pump

4-3
 WARNING

 Push down the handle after correct installation of the infusion tube when
the pump is in Power On mode. If the running indicator light illuminates,
it means that the infusion tube is correctly installed.Otherwise, the
infusion tube needs to be reinstalled.
 When using the same infusion tube, change the part of the tube that is
clamped in the groove of the machine every 4 hours.The infusion tube
must be replaced once it has operated continuously for over 24 hours.
 If the infusion tube is loose or pulled too tightly, this may cause an
abnormal infusion volume.
 The double thickness of the infusion tube should be between 0.8
mm–1.2 mm. The outer diameter should be between 3.5 mm–4.5 mm.
Otherwise, its accuracy cannot be guaranteed, and may cause serious
injury to patients.

CAUTION

 After installation of the infusion tube and before infusion, check for
leakages. If any are found, they should be rectified as soon as possible.

4.2.3 Setting Parameters

Press the key to switch the infusion mode.

The procedure for setting the parameter values in each infusion mode is as follows:

Step 1: Press the or key to move the cursor up or down and select the
parameter that requires setting;

Step 2: Press the key to enable the currently selected parameter to be adjusted;

Step 4: Select the increment/decrement step depending on the required parameter

value.Press the key to cycle through the steps: 0.1, 1, 10, 100, and 1000.

4-4
Step 5: After selecting the step, press the or key again to increase or
decrease the current parameter value by the selected step.Step 6:Repeat the above

operations to set the other required values.Finally, press the key to save the
settings.

NOTE

 The rate cannot be set in Time Mode.

 When setting decimal digits, press the key so that the

increment/decrement step in the upper right corner is 0.1, and then
increase and decrease the digit accordingly.

 When selecting the parameter that requires setting, pressing the

or key will not affect the step.

 The accumulated volume (Σ) is the fluid volume that has accumulated

during the infusion, and cannot be set. Press the key in stop
status to clear the accumulated volume.

4.2.4 Zeroing the Volume

In stop status, press the key to clear the accumulated volume.

NOTE

 The accumulated volume can only be cleared when the infusion pump is
in stop status.

4-5
4.2.5 Starting the Infusion
After setting all the parameters and installing the infusion tube correctly, press the

key. The motor will begin to run and the pump will start infusing. The running
indicator light will flash during infusion.

NOTE

 The pump will stop working automatically once the critically low battery
alarm sounds during infusion.

4.2.6 Infusion Finished

When the accumulated volume reaches the volume limit, the LCD will display “Finish”
and emit an audible alarm to alert the user that the infusion is finished. Press the

key to stop the infusion.

4.2.7 Turning off the Pump

Follow the steps below to turn off the infusion pump:
1. Disconnect the infusion tube between the patient and the pump.

2. Press and hold the key until the Power Off progress bar completes, then
release the key and the power will turn off.

NOTE

 The flow rate and other parameters will reset to the default values after
the machine is turned off.
 Parameters in Advance Settings will be permanently saved after the
machine is turned off.

4-6
5 Functions and Screens
5.1 Infusion mode

After the infusion pump is turned on by pressing the key, the pump defaults to Rate
Mode if the previous settings are not used. You can switch to other infusion modes by

pressing the key. As shown below, pressing the key sequentially displays
the setting screens for Rate Mode (Fig. 5-1), Time Mode (Fig. 5-2) and BW Mode (Fig.
5-3).

Figure 5-1 Figure 5-2 Figure 5-3

In the Rate Mode setting screen, simultaneously pressing the and keys
switches to Drop Mode. Repeat the operation to return to Rate Mode.

WARNING
 Please do not turn on Drop function infusion if no drop sensor is
installed.

5-1
 NOTE

 Different parameters must be set depending on the selected infusion

mode. See Table 1 for details.
 If the Drop function is turned on with no drop sensor installed and the
user enters any infusion mode, the information bar will display a "Drops
Error" alarm message but will not immediately stop infusion.
 The drop sensor is only part of the infusion rate detection function and
cannot analyze or determine leakage.

Table 1
Infusion
Parameters Parameter Range and Description
Mode

Drop 1-133 drops/min (range is determined by the Drops/ml

Drop Mode t )
Volume 0–9999.9 ml

Flow rate 0.1–2000.0 ml/h

Flow Rate
Mode
Volume 0–9999.9 ml

Time 1–6000 min

Vol. 0.1–9999.9 ml
Time Mode

Range is 0.1–2000.0 ml/h. Specific values are

Flow rate
determined on the basis of time and

Weight 0.1 - 300.0kg

Dosage 0.1 - 999.9mg

Drug unit mg, g (the default unit for dosages is mg)

Vol. 0.1 - 999.9ml

Bodyweight
Dose 0.1–999.9
(BW) Mode
Dose unit mg/kg/h , ug/kg/min

Volume 0–9999.9 ml

Range: 0.1 - 2000.0 ml/h. Specific numerical values

Flow rate are determined on the basis of weight, dosage, fluid
volume and dose parameters.

5-2
 5.2 Advance Setting

When stopped, simultaneously press the key and release the key in the
Infusion Mode Setting screen to enter the Advance Setting screen. The three pages
are shown below in Fig. 5-4, Fig. 5-5 and Fig. 5-6, respectively.

 Press the key to start setup.

 When setup is complete, press the key to save.

 Press the key to exit the Advance screen.

Figure 5-4 Figure 5-5 Figure 5-6

Parameters can be set in the Advance Setting screen as shown in Table 2 below:

Table 2
Settable
Parameter Description
Parameters
Bed No. 1 - 1000
0.1-5.0 ml/h.When infusion is finished, enter KVO mode to continue
running and display the infusion finished report and KVO Rate.The
KVO Rate
KVO volume is added to the total volume and is not displayed
separately.
Manual Bolus adjustable between 100.0 -1000.0 ml/h. Default is 600.0 ml/h.
Tube A, Tube B, Tube C. The user can customize the brand according
Tube to requirements.In order to prevent the mixing of brands, please
record the brand represented by each tube for inspection.
Accuracy 30-108, using a calibrated tube.
Divided into three levels: low, mid and high. The corresponding
pressures are 70 kPa, 100 kPa and 130 kPa respectively (may
Occlusion threshold
fluctuate by ±30 kPa). Default level is "Low".
If occlusion occurs during the infusion process an "Occlusion" alarm

5-3
 will be triggered. The infusion pump will enter Anti-Bolus status and
the motor will reverse every 5 seconds.When the motor reaches the
maximum number of reversals, Anti-Bolus will stop and the motor will
enter Stop status.The maximum number of reversals is related to the
occlusion level. The maximum number of reversals for high, mid and
low occlusion levels is 5, 4 and 3 respectively.
Tube specifications and parameters, i.e. the number of drops
Drops/ml contained in 1ml of the drug. Please see tube packaging for
values.Range: 10-60 drop/ml. Default: 20 drop/ml.
Used to set the alarm sensitivity for microscopic air bubbles. Four
levels: Close and levels 1-3. Default is "Close".The higher the filter
AirLevel
level, the larger the capacity of the air bubbles allowed through the
filter.
Used to start and stop the drop function.Also monitors the drop rate
Drop Function
when the infusion pump is stopped.
Can set as off or between 1-5 mins. Default is "Off".Used to set the
Lock Time
keypad locking time.
KeySound On, off.Used to start and stop KeySound.
Audible Alarm
High, mid, low.Used to set the alarm volume.
Volume

Can set as off or between 1-5 mins. Default is "Off".When the

Reminder button is pressed and infusion is possible, this function will trigger a
"Reminder" alarm when no operations or alarms have occurred within
a set period of time, prompting the user to start the infusion pump.
Language Switch between Simplified Chinese, English, Spanish and French.
On, off. Default is "Off".When set to "On", all current Advance screen
Default parameters will be reset to default and the default function will return
to "Off" mode.
Accuracy Used to enter the Accuracy Calibration screen to carry out accuracy
Calibration calibration.
Used to enter the Pressure Adjust screen to carry out pressure
Pressure Adjust
adjustment.
Used to enter the Record screen to view the historical usage records
Record
of the infusion pump.

NOTE

 The drop function is an optional function and can only be used in

conjunction with the optional drop sensor accessories.
 Parameters in Advance Settings will be permanently saved after the
machine is turned off.

5-4
5.2.1 Bolus Function
During infusion, there are two ways to deliver bolus infusion: Auto Bolus or Manual
Bolus.

NOTE
 Bolus injection can only be started if the current rate is lower than the
current bolus rate setting.

5.2.1.1 Auto Bolus Function

When the pump is running, press and release the key to enter the Bolus

Settings screen as shown in Fig. 5-7, press the key to enable value adjustment,

then press or to set the bolus preset volume limit and bolus rate. After

setting the parameters, press the key to confirm. Finally, press and release the

key to start bolus; the Bolus screen will appear as in Fig. 5-8.During bolus

infusion, press the key to stop bolus and return to the original infusion rate.

Figure 5-7 Figure 5-8

NOTE
 Auto Bolus preset volume limit setting range is 0.1–99.9 ml. Default is 0.1
ml.
 Auto Bolus rate setting range: greater than or equal to the current infusion
rate, less than or equal to the maximum infusion rate.
 If no operation is performed within 5 seconds, the pump will automatically
exit the Bolus Settings screen and the procedure must be repeated.

5-5
5.2.1.2 Manual Bolus Function

When the pump is running, hold down the key. The pump will speed up
infusion to the bolus rate for the current syringe, and the Run screen will appear as

shown in Fig. 5-8.After the key is released, the infusion rate will return to its
original value.

5.2.1.3 Manual Bolus Infusion Settings

The manual bolus rate for this infusion pump is adjustable.Select "Bolus Rate" on the

first page of the Advance Setting screen (shown in Fig. 5-9). Press the key to

enable value adjustment, and set required values by pressing the key or the

key (within a range of 100.0-1000.0 ml/h).Finally, press the key to save.

Figure 5-9

NOTE
 The bolus function should only be used when infusion is proceeding
normally.
 Bolus does not affect any of the alarm functions.
 The bolus rate for this infusion pump is adjustable within a range of
100.0–1000.0 ml/h. Default is 600.0 ml/h.
 The bolus function cannot be started if the current rate is greater than
the set bolus rate.
 The bolus flow volume is added to the cumulative total.
 When the rate exceeds 400 ml/h, the drop rate monitoring function will
shut down automatically.

5-6
5.2.2 Drop Rate Function and Setting (Optional)

NOTE

 Setting the drop function requires system software support. For details
regarding this optional software, please consult the manufacturer or the
dealer from whom you purchased this product.

WARNING
 The drop sensor is not applicable to light-proof medicine infusions.
Adopting light-proof IV sets on the pumps might cause the drop sensor to
fail and result in serious injury to patients.

5.2.2.1 Starting the Drop Rate Function

Select "Drop Function" on the second page of the Advance Setting screen (shown in

Fig. 5-10). Press the key to enable value adjustment, and set the function to

"On" by pressing the key or the key to start the drop function.The drop
function default for this infusion pump is "Off". This is an optional function. For further
information, please consult the manufacturer or the dealer from whom you purchased
this product.

Figure 5-10

5-7
5.2.2.2 Setting the Drop Rate for the Infusion Tube
The tube drop parameters will be different for different brands. Please refer to the
parameter descriptions on the packaging of each tube for details.
Select "Drops/ml" on the first page of the User Settings screen (shown in Fig. 5-11).

Press the key to enable value adjustment, and press the key or the

key to set the corresponding drop parameters for each infusion tube.Press the

key to save.

Figure 5-11

NOTE
 The range of parameters for tubes is:10-60 drop/ml.

5-8
5.2.2.3 Viewing the Drop Rate screen

In the Rate Mode Settings screen, simultaneously press the key and the
key and then release them to switch to Drop Mode, as shown in Fig. 5-12. Repeat to
return to Rate Mode.

Figure 5-12

NOTE
 Drop rate can be monitored in any mode once the drop function has
been started. Drop rate cannot be monitored if the drop function has not
been started.

5.2.3 Using a Different Brand of Tube

Calibrations for this infusion pump are performed using "Bao An" disposable infusion
tubes and the pump is designed for use in conjunction with this brand of tube. If the user
uses tubes other than "Bao An" brand tubes, new accuracy calibrations and pressure
adjustments must be made.

NOTE
 Accuracy calibration and pressure adjustment should be carried out
after changing the infusion tubes used with this infusion pump, prior to
first use, after 6 months of continuous use or after maintenance or
upgrading.

5-9
5.2.3.1 Accuracy Calibration
1. Select "Accuracy Calibration" on the second page of the Advance Setting screen

and press the key to enter the Accuracy Calibration screen;

2. Set the calculation rate (between a range of 50-500 ml/h, recommended value: 300
ml/h);
3. Install the infusion tube as normal, insert into a 100 ml measuring cup and press

the key to start calculating. The screen will display the time remaining;

4. Measure the amount of liquid in the measuring cup once the infusion pump has
stopped running;
5. Enter the actual obtained volume into "Actual Volume";

6. Press the key to exit and save.Note:press the key to exit without
saving.

Figure 5-13 Figure 5-14 Figure 5-15

NOTE
 In order to reduce accuracy testing errors, fill the tube with liquid and
ensure there are no air bubbles before testing.

5.2.3.2 Pressure Adjust

Select "Pressure Adjust" on the third page of the Advance Setting screen and press

the key to enter the Pressure Adjust screen;

1. Connect the tube and pressure gauge to the infusion pump.

2. Set the rate (recommended rate is 100 ml/h. Higher speeds are possible if a
pressure gauge is used).

5-10
3. Press the key to start infusion. When the needle on the pressure gauge

reaches 100 kPa or above press the key.

4. When the "pressure" has fallen to 100 kPa (the "pressure" can also be set

manually so that it is consistent with the pressure gauge) press the key.

5. Press the key to exit and save.Note:Press the key to exit without
saving.

Figure 5-16

WARNING
 The Pressure Adjust screen has no occlusion alarm. To avoid risk of
serious harm to patients, do not perform infusion in this screen.

NOTE

 The range of factors is 0.5-2. If the factors exceed this range when
saving, the system will automatically return to the last default pressure
adjust value in the Advance Setting screen.
 Pressure adjustments must be carried out on any tubes that are
especially hard or soft;The pump cannot be switched off directly from
the Pressure Adjust screen.
 Install the tube correctly. The tube must be positioned appropriately to
ensure that there are no air bubbles in the tube.

5-11
5.2.4 Occlusion Level Settings
Select "Occlusion Level" on the first page of the Advance Setting screen (shown in

Fig. 5-17). Press the key to enable value adjustment, and press the key

or the key to select the appropriate occlusion level.Press the key to

save.
The occlusion level is related to the number of reversals in Anti-bolus status.

Figure 5-17

NOTE
 The lower the occlusion level, the higher the occlusion sensitivity.

5.2.5 AirLevel Settings

Select "AirLevel" on the first page of the Advance Setting screen (shown in Fig. 5-18).

Press the key to enable value adjustment, and press the key or the

key to select the appropriate air level.If AirLevel is set to Off, no air bubbles are

allowed to pass, otherwise an alarm will be triggered.Press the key to save.

NOTE

 The higher the AirLevel, the larger the capacity of the air bubbles
allowed through the filter.

5-12
 Figure 5-18

5.2.6 Reminder Settings

The infusion pump is equipped with a "Reminder" alert function to remind users to
start the pump promptly after the tube has been correctly installed, in order to avoid
treatment delays.If the user does not start infusion within the set time period after the
tube has been correctly installed, the infusion pump will issue a "Reminder" alarm
prompt.
Select "Reminder" on the second page of the Advance Setting screen (shown in Fig.

5-19). Press the key to enable value adjustment, and press the key or

the key to select the appropriate prompt time limit. This function can also be
set to "Off".

Press the key to save.

Figure 5-19

5-13
5.2.7 Locktime Settings
In order to prevent the patient touching the keys on the infusion pump or abnormal
infusion occurring due to uncertain factors during the infusion process, the infusion
pump is equipped with a key lock function.There are two locking methods: automatic
and manual.

 Automatic Locking: Simultaneously press the and keys to enter the

Advance Setting screen. Go to the second page (as shown in Fig. 5-20) and set the
lock time.If the Run screen is turned on and there have been no keyboard operations
within the set time period, the keyboard will lock.

 Manual Locking: Press and hold the key in the Run screen to lock the
keyboard.

 Unlocking: Press and hold the key to unlock the keyboard in all lock
statuses.If an alarm is triggered, the infusion pump will unlock automatically.

Set Unlocking Times Unlocked Locked

Fig. 5-20 Fig. 5-21 Fig, 5-22

NOTE

 The above locking and unlocking functions are only effective in the Run
screen.
 If an alarm is triggered, the infusion pump will unlock automatically.

5-14
5.2.8 Audio Volume
Both the Alarm Volume and the KeySound for this infusion pump are adjustable. The
user can set the Alarm Volume to high, medium or low level as required.KeySound
can be set as "On" or "Off".

On the second page of the Advance Setting screen (Fig. 5-23 shows the Alarm
Volume Settings screen and Fig. 5-24 shows the KeySound setting screen).Select

the appropriate volume level and press the key to save.

Fig. 5-23 Fig. 5-24

5.2.9 Language Options

Select "Language" on the second page of the Advance Setting screen. Press the

key to enable value adjustment, and press the key or the key to

select the required language.Press the key to save.

Fig. 5-25

5-15
5.2.10 Record
Record enables the user to view the historical usage records of the infusion
pump.The following events and content can be recorded:
 Power on (state, time)
 Start (state, time, rate, drug, preset volume limit)
 Stop (state, time, accumulated volume, drug)
 Bolus (state, time, bolus rate)
 Rate change (state, time, new rate)
 KVO (state, time, KVO rate)
 Alarm (state, time, alarm reason)

A record is created whenever the above events occur. The memory can store up to
1500 records. Once the memory is full, the oldest records will be overwritten
first.Select "Record" on the third page of the Advance Setting screen and press the

key to enter the Record screen. All records have a serial number and are

displayed in reverse order. Press the key to view the previous record, press the

key to view the next record.Press the key to exit the Record screen.

Figure 5-26

5.3 Purge
During infusion, the user should prevent air bubbles from entering the blood with the liquid
drug, which may form an aeroembolism and put patients in serious danger. Therefore, air
bubbles in the infusion tube should be eliminated before the infusion. On the parameter

setting interface, hold down , you will be prompted with “Disconnect pump from

5-16
patient! Press and hold “OK” to purge”. Then hold down to purge the system at the

set rate, release after the air bubbles are purged, completing the purge.

WARNING
 During the purge, please disconnect the pump from the patient.
Otherwise, the patient will be in serious danger！
 Purge rate is the same as manual bolus rate. Set the purge rate in the
parameter Seting Interface, please refer to 5.2.Advance Setting.
 The purge accumulated volume is not added to the total volume.

5.4 Changing the Rate during Operation

In the Rate Mode screen, press the key as shown in Figure 5-27 to edit the

rate.Press the key to select a suitable step rate and press the key or the

key to set the required rate value.After setting a new rate, press the key.

A confirmation box will pop up as shown in Figure 5-28. Press the key or the

key to confirm. Select 'Yes' to infuse at the new rate or 'No' to continue infusing
at the original rate.

Figure 5-27 Figure 5-28

NOTE
When changing the rate in Run state, if no operation is performed within 5
seconds, the setting process will fail and must be restarted.

5-17
5.5 Automatic Pressure Release Function (Anti-Bolus)
If occlusion occurs during infusion, an occlusion alarm will be triggered. The motor
will reverse and pressure will be released automatically.The motor will remain in
reverse until the pressure limit is reached.

5.6 Memory Function

The memory function saves the pump infusion parameters before power off, so that
the next time the pump is powered on, the user can quickly start infusion with the
most recently used parameters.After the pump is powered a dialog box will appear as

shown in Fig. 5-22. Press the key or the key to toggle between “Yes”

and “No”.If you press the key to select “Yes”, then the pump enters the Rate
Mode setting screen and loads the most recently used Rate and PreS values. The
drug parameter defaults to “No Drug”. Make sure that it is safe to proceed, then press
the Start key to commence infusion.If you select “No”, then the last infusion
parameters are automatically cleared and the normal operating process is followed.

Figure 5-29

5-18
5.7 Drug Library
This product is equipped with a drug database to facilitate drug selection.In any

infusion mode setting screen, press the key to move the cursor to “Drug” as

shown in Fig. 5-30, then press the key to enter the Drug Base screen as shown

in Fig. 5-31.Press the key or the key to browse the full list of drugs,
which are displayed in alphabetical order. There are 40 drugs to choose from;

seeTable 3 for the full list.Press in this screen to select the highlighted drug
and exit the screen.After the drug is selected, its name will appear on the Run screen.

Figure 5-30 Figure 5-31

5-19
 Table 3
No. Drug No. Drug

1 Aminophylline 21 Magnesium sulfate

2 Amiodarone 22 Mannitol

3 Atropine 23 Metaraminol Bitartrate

Dexmedetomidine
4 24 Metoprolol Tartrate Tablets
Hydrochloride Injection
5 DiaZepatn 25 Midazolam

6 Diazoxide 26 Morphine

7 Digoxin 27 Nicardipine

8 Diltiazem 28 Nimodipine

9 Dobutamine Hydrochloride 29 Nitroglycerin

10 Dopamine Hydrochloride 30 Noradrenaline Bitartrate

11 Epinephrine 31 Pancuronium

12 Esmolol 32 Phentolamine

13 Fentanyl 33 potassium chloride

14 Flumazenil 34 Propafenone Hydrochloride

15 Furosemide 35 Propofol

16 Heparin Sodium 36 Remifentani

17 Insulin 37 Sodium Nitroprusside

18 Isoprenaline Hydrochloride 38 Suxamethonium

19 Isosorbide dinitrate 39 Urapidil

20 Lidocaine Hydrochloride 40 vasopressin

5-20
 6 Alarms
6.1 Description
Alarms refer to the use of both sound and information displays to alert health care
workers to any abnormalities in the infusion circuit or any faults occurring with the
infusion pump itself during the infusion process, affecting the pump's ability to provide
smooth infusion to the patient.

WARNING
 It is potentially hazardous to use the same or similar equipment with
different alarm presets within the same area.

6.2 Alarm level

Color of alarm Audible alarm Flashing light Light/no-light
Alarm level
light frequency frequency ratio

High-level
Red 10 seconds 2.0±0.6Hz 20%-60%
alarms

Mid-level
Yellow 15 seconds 0.6±0.2Hz 20%-60%
alarms

Low-level
Yellow 20 seconds Steady 100%
alarms

6.3 Alarm types

When an alarm occurs, the infusion pump will use both visual and auditory
methods to alert the user:
 Visible alarms
 Audible alarm
 Alarm Information
There are visible and audible signals for different alarm types.

6-1
6.3.1 Visible alarms
Visible alarms are flashing indicator lights when an alarm is triggered. Different
alarms trigger different colored indicator lights.

6.3.2 Audible alarm

Sound alarms refer to the use of different sounds to provide alerts for different alarm
levels when an alarm is triggered.
 Single alarm:A single alarm sound repeats on a loop.
 Multiple alarms:Multiple alarms repeat on a loop.

6.3.3 Alarm Information

Screen alarm refers to the alarm information that is displayed in the status bar when
an alarm is triggered.
 If an alarm is triggered, the pump will cycle between light alarm, sound alarm and
screen alarm.
 If a pressure sensor detects pressure above the threshold limit, an alarm will be
triggered.

Alarm types:
 Air Bubble
 Finish
 Occlusion
 Check Tube
 Battery Empty
 System Error
 Motor Error
 Drops Error
 Parameter Error
 Low battery
 Reminder
 Handle Open
 AC Disconnect

6-2
6.4 Alarm Countermeasures
When an alarm is triggered, please refer to the following steps and take appropriate
measures:
1. Check the patient;
2. Check the alarm type and the parameter which triggered the alarm;
3. Determine the reason for the alarm;
4. Eliminate the reason for the alarm;
5. Check whether the alarm has cleared.

NOTE
 Please refer to C - Alarm Information for the specific handling
procedures for each alarm.

6-3
FOR YOUR NOTES

6-4
A Product Specifications
A.1 Safety Specifications
Parameters Specifications

China SFDA
Ⅱ
Classification

IEC protection class Ⅱ, including internal power supply equipment

Level of electrical
CF
protection

Liquid ingress protection IP21

Operating mode Continuous running

Mobile level Portable equipment

A.2 Operating Environment

Parameters Specifications

Operating temperature 5 - 40ºC

Operating humidity 20–80%, non-condensing

Operating atmospheric
86–106 kPa
pressure
Transport and storage
-20–55ºC
temperature
Transport and storage
10–95%, non-condensing
humidity
Transport and storage
50–106 kPa
atmospheric pressure
Storage conditions In a room with no corrosive gases and good ventilation

A-1
A.3 Power Supply
Parameters Specifications
Alternating current power supply (AC)
Voltage 100–240 V
Current 0.25-0.11A
Frequency 50/60 Hz
Battery
No. of batteries 1
Battery type Rechargeable battery
Rated battery voltage DC 7.4 V
Capacitance 1600 mAh (2400mAh Optional)
Maximum power and 25VA. Able to run normally for at least 2 hours at a rate of
operating time 25 ml/h after charging (2400mAh).
The battery will charge automatically when the infusion
Recharging the battery pump is connected to an AC power source and turned on
(it takes 8-14 hours to fully charge the battery).

A.4 Hardware Specifications

Parameters Specifications

Pump unit

Size 120mm × 140mm × 195mm (length x width x height)

Weight ≈1.8 kg

Display

Type Color LCD

Size 3.0 inches

Indicator lights

No. 4
Fuse
Pressure resistance, flow
T 2 A 250 V～
resistance

External ports

Power source 1 AC socket

Data ports 1 drop rate sensor interface

A-2
A.5 Auditory Indicator
Speaker Produce an alarm (the sound pressure is 45 - 80 dB)

A.6 Basic Infusion Pump Parameters

Parameters Specifications

Tube standards In compliance with "GB 8368-2005 Disposable Infusion Sets,

Infusion pump
Peristaltic
mechanism

Range of infusion
0.1-2000.0 ml/h.
rates

Manual Bolus
100.0 -1000.0 ml/h. Default is 600.0 ml/h.
rate

Auto Bolus
0.1-99.9 ml. Default is 0.1 ml.
preset volume

Rates can be set

in the following 0.1, 1, 10, 100, 1000
steps

Increments 0.1

Infusion Mode
RateMode, TimeMode, BW.Mode, DropMode (optional)
Options

Drop Mode Drop rate:1-133 drops/minute

Flow Rate Mode Rate:0.1-2000.0 ml/h.

Time:1-6000 minutes
Vol.:0.1 - 9999.9 ml
Time Mode
Rate: Range is 0.1–2000.0 ml/h. Specific values are determined on
the basis of time and volume.

A-3
 Weight:0.1 - 300.0kg
Dosage:0.1 - 999.9mg
Dose unit:mg, g (the default unit for dosages is mg)
Vol.:0.1 - 999.9ml
Bodyweight (BW)
Mode Infusion dosage:0.1–999.9
Dosage unit:mg/kg/h, ug/kg/min
Rate: Range: 0.1 - 2000.0 ml/h. Specific numerical values are
determined on the basis of weight, dosage, fluid volume and dose
parameters.

Adjustable range:0.1-5.0 ml/h (Start KVO after infusion has

KVO rate
finished)

Drops/ml Tube specifications and parameters, i.e. the number of drops

contained in 1ml of the drug. Please see tube packaging for
values.Range: 10-60 drop/ml. Default: 20 drop/ml.

Range of preset
0 - 9999.9 ml
infusion volumes

Range of preset
1-6000 mins
times

Display
cumulative 0.1 - 9999.9 ml
volumes

Infusion
±5%
accuracy

Display Rates, preset volumes, cumulative volumes, battery capacity,

information pressure and AC power source indicators.
Air Bubble, Finish, Occlusion, Battery Empty, System Error, Motor
Alarm
Error, Drops Error, Parameter Error, Low Battery, Tube Error,
Information
Reminder, Handle Open, AC Disconnect
Status indicators Stop, infusion, bolus, KVO

Air bubble The minimum detectable volume for air bubbles at a rate of 600
measurement ml/h is 0.005 ml
The maximum producible pressure is 160 kPa. The pressure
Infusion pressure threshold range in which the occlusion alarm will sound is 40-160
kPa. The time of occlusion alarm please refer to A.7.

A-4
A.7 Occlusion Alarm Pressures, Delays for Alarm
Times and Maximum Permissible Dose Volumes

Occlusion
Actual pressure Time to
threshold Flow rate Bolus
at alarm alarm
pressure (ml/h) (ml)
(kPa) (Min)
(kPa)
5 70.93 00：06：50 0.190
70±30 100 70.67 00：00：17 0.283
500 70.80 00：00：03 0.250
5 99.37 00：08：57 0.288
100±30 100 99.20 00：00：30 0.304
500 100.60 00：00：06 0.305
5 130.50 00：12：29 0.378
130±30 100 130.90 00：00：33 0.330
500 130.00 00：00：12 0.663

NOTE

 Test conditions:

 FLUKE IDA4 PLUS tester.

 Infusion set brand:"Bao An".

 Pressure at alarm, alarm delays and bolus volume may vary depending on
test conditions.
 The data above are only typical values under the testing conditions, and
the actual data may vary against different testing conditions. Please rely
on data obtained from the testing on the product you buy. The bigger the
measured pressure under the same reference clogging value and the same
flow velocity is.

A-5
A.8 Infusion Accuracy Table
The following infusion accuracy table expresses performance after infusion has
started and infusion fluctuations occurring within a certain period of time after normal
infusion flow volumes have been reached.

A.8.1 Accuracy Curve

Plotted on the basis of data collected over a two-hour measurement period.

Sampling rate:25 ml/h

Sampling interval:△t =0.5 mins
Test period:T =120 mins
Infusion rate:Q (m/h)

A-6
A.8.2 Bell-shaped Curve
Flow rate deviation over time (p△t)

Sampling rate:25 ml/h

Sampling interval:△t =0.5 mins
Observation windows:p△t = 2, 5, 11, 19, 31 mins
Maximum deviation over the course of a full observation window:EPmax (%)
Minimum deviation over the course of a full observation window:EPmin (%)
Average deviation:A (%)

NOTE

 Infusion accuracy does not reflect clinical criteria, such as patient age and
weight and the specific drug used.
 Infusion accuracy may be affected by the pump environment (such as
pressure, temperature, humidity and any infusion accessories used).

A-7
FOR YOUR NOTES

A-8
B EMC and Radio Regulatory Compliance
B.1 EMC
This infusion pump complies with EMC standard EN 60601-1-2.

NOTE
 Use of accessories, sensors or cables outside of the specified scope of
this pump may increase electromagnetic emissions and/or lower the
electromagnetic immunity of the pump.
 This infusion pump may not be used in close proximity to or stacked
with other equipment.If necessary, closely observe the pump to ensure
that it is able to operate normally under the current configuration.
 Special protection must be given to the electromagnetic compatibility of
the infusion pump. Installation and maintenance must be carried out in
an environment that satisfies the following EMC information.
 The infusion pump should not be used at the same time as any MRI
(Magnetic Resonance Imaging) or other similar equipment, to avoid the
possibility of the pump malfunctioning or crashing due to
electromagnetic interference.
 Even if other equipment is compliant with CISPR emission requirements,
it may still cause interference and affect how the pump operates.
 Where electromagnetic signals are weaker than the measuring device's
sensitivity range, measurements may be inaccurate.
 Portable and mobile RF communications equipment can affect the
performance of measuring devices.

B-1
 Guidance and statements regarding electromagnetic emissions
This infusion pump should be used in the stipulated electromagnetic environments. The
customer or user should guarantee that the infusion pump is used in an
electromagnetic environment that complies with the following regulations:

Emission test Standard Electromagnetic environment - guidance

RF emissions Group 1 The infusion pump only uses radio frequency

CISPR 11 energy when running internal functions. The
pump's radio frequency emissions are therefore
very low and will not cause any electromagnetic
interference in nearby electronic equipment.

RF emissions Class B
CISPR 11

Harmonic emissions Class A

IEC61000-3-2

Voltage fluctuations Compliant

and scintillation
IEC 61000-3-3

B-2
 Guidance and statements regarding electromagnetic immunity
This infusion pump should be used in the stipulated electromagnetic environments. The
customer or user should guarantee that the infusion pump is used in an electromagnetic
environment that complies with the following regulations:

Immunity test IEC60601 test level Standard Electromagnetic

environment - guidance

Electrostatic ±6 kV contact ±6 kV contact Flooring must be wood,

discharge discharge discharge concrete or ceramic tile.If
(ESD) ±8 kV air discharge ±8 kV air discharge the floor is lined with
IEC 61000-4-2 synthetic materials there
must be a relative
humidity of at least 30%.

Electrical fast ±2 kV power cord ±2 kV power cord The network power source
transient ±1 kV I/O cable must be of typical
(EFT) commercial or hospital
quality.
IEC 61000-4-4

Surge ±1 kV differential ±1 kV differential

IEC 61000-4-5 mode mode
±2 kV common ±2 kV common
mode mode

Voltage drops, ＜ 5% UT(drop ＞ ＜ 5% UT(drop ＞ The network power source

short 95% UT) 0.5 cycles 95% UT) 0.5 cycles must be of typical
interruptions commercial or hospital
and changes quality.If the infusion
40% UT(drop 60% 40% UT(drop 60%
IEC 61000-4-11 pump needs to run
UT) 5 cycles UT) 5 cycles
continuously we
recommend using an
70% UT(drop 30% 70% UT(drop 30% uninterruptible power
UT) 25 cycles UT) 25 cycles supply UPS in case of
interruptions in network
＜ 5% UT(drop ＞ ＜ 5% UT(drop ＞ power.
95% UT) 5 seconds 95% UT) 5 seconds

Power 3 A/m 3 A/m The power frequency

frequency magnetic field must be at
magnetic field a typical level for typical
(50/60 Hz) commercial or hospital
environments.
IEC 61000-4-8

NOTE:UT refers to the voltage of the AC power network before voltage testing

B-3
 Guidance and statements regarding electromagnetic immunity
This infusion pump should be used in the stipulated electromagnetic environments. The
customer or user should guarantee that the infusion pump is used in an electromagnetic
environment that complies with the following regulations:

Immunity IEC 60601 Electromagnetic environment -

test Test level Standard guidance

Conducted 3 Vrms 3V Portable and mobile radio frequency

immunity 150 k–80 MHz communications devices must be used at
IEC61000-4-6 the stipulated distance away from the
infusion pump or any system components
Radiated 3 V/m 3 V/m
(including the cables).This isolation
immunity 80 M–2.5 GHz distance is calculated using appropriate
IEC61000-4-3 formulas selected on the basis of the
frequency of the radiation.Recommended
calculation formulas for isolation distance
are:

d = 1.2 P
d = 1.2 P 80 M–800 MHz
d = 2.3 P 800 M–2.5 GHz
where P is the rated maximum output
power of the transmitter, in W.d is the
recommended distance, in m.
The field strength of the radio frequency
transmitter obtained by measuring the
electromagnetic fielda must be within
compliant levels for every frequency
rangeb.
May cause interference if used in close
proximity to equipment with the following
symbols:

Note 1:Between 80 MHz–800 MHz, use a formula for higher frequency bands.
Note 2:The above guidance is not suitable for use in all conditions. Material structures,
objects and people can absorb and reflect electromagnetic waves, affecting
electromagnetic propagation.

B-4
a
Field strengths for radio (honeycomb and wireless) handset base stations and terrestrial
mobile radio receiving apparatus, antenna reception apparatus, and FM and AM
radio/television broadcasts cannot be accurately estimated using a purely theoretical
approach.
The use of electromagnetic field measuring methods should be considered when
estimating the electromagnetic environment produced by a fixed radio frequency
transmitter. If the measured field strengths in the environment in which this infusion pump
is used exceed stipulated RF levels, the infusion pump must be observed to check
whether normal operation is possible.Relevant measures must be taken as soon as
abnormalities are discovered, such as changing the position of the infusion pump or
moving it to another environment.
b
In a frequency range of between 150 k–80 MHz, field strength should be less than 3
V/m.

It is recommended that the infusion pump be kept away from portable/mobile

RF communications equipment
The infusion pump can be used in electromagnetic environments in which RF
interference is controlled.In order to avoid electromagnetic interference, the customer or
user should maintain the minimum recommended distance between the infusion pump
and portable/mobile RF communication equipment.The following recommended
isolation distances are calculated on the basis of the maximum output power of the
communications equipment.

Transmitter Calculate isolation distances on the basis of

ratings transmitter frequencies (m)
Maximum output 150 k–80 MHz 80 M–800 MHz 800 M–2.5 GHz
power
(W) d = 1.16 P d = 1.16 P d = 2.33 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23
If the rated maximum output power of the transmitter is not included above, the isolation
distance may be estimated by using the formula in the corresponding column.In the
formula, P is the rated maximum output power of the transmitter as provided by the
manufacturer, in W.
Note 1:Between 80M-800MHz, use a formula for higher frequency bands.
Note 2:The above guidance is not suitable for use in all conditions. Material structures,
objects and people can absorb and reflect electromagnetic waves, affecting
electromagnetic propagation.

B-5
B.2 Radio Regulatory Compliance

RF Parameter
Description
Item
IEEE 802.15.4
Operating Frequency
2400-2483.5MHz
Band (MHz)
Modulation OQPSK
Transmitter Output
＜20dB
Power (Typical)(dBm)

The device configured with the Xbee-PRO wireless module complies with part 15 of
the FCC Rules. Operation is subject to the condition that this device does not cause
harmful interference.

FCC Compliance of the device configured with Xbee-PRO wireless module : This
device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference, and (2)this device
must accept any interference received, including interference that may cause
undesired operation. Any changes or modifications to this equipment not expressly
approved by our company may cause harmful radio frequency interference and void
your authority to operate this equipment.

This radio device used in this product is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC(Radio Equipment
and Telecommunications Terminal Equipment Directive).

WARNING
 Keep a distance of at least 20cm away from the device when Xbee-PRO
wireless module function is in use.

B-6
 C Alarm Information
C.1 Alarm Information
NOTE:column A shows whether the alarm can be completely cleared;Column B
shows whether the sound and light can be cleared;column L shows the alarm level.
Alarm Information display A B L Cause Action required

Air Bubble Yes No High Air bubbles in

the tube. Press the key to
stop infusion and turn
off the alarm. Eliminate
the air from the tube

and press the

key to restart infusion.

There is a fault Contact the

with one of the manufacturer.
infusion pump
sensors.

Finish Yes No High Infusion

Press the key to
volumes have
already been stop infusion and turn
set. off the alarm. Press the

key to clear the

accumulated volume,

then press the

key to restart infusion.
Occlusion Yes No High The infusion
circuit is Press the key to
blocked. stop infusion and turn
off the alarm. Eliminate
the blockage and press

to restart
infusion.

Occlusion Raise the occlusion

threshold is too level.
high.

C-1
 Alarm Information display A B L Cause Action required

There is a fault Contact the

with one of the manufacturer.
infusion pump
sensors.

Check Yes No High Infusion tube Reinstall the tube

Tube not installed correctly, ensure that
correctly, handle is not protruding
handle is from side and that
protruding at running indicator light
the side. is on.

There is a fault Contact the

with one of the manufacturer.
infusion pump
sensors.

Battery No No High Battery is too Connect an AC power

Empty low. source and recharge
the battery.
The battery is Contact the
old or there is manufacturer.
a fault with the
charging circuit
of the infusion
pump.

System Yes No High Data Contact the

Error communication manufacturer.
error.

C-2
 Alarm Information display A B L Cause Action required

Motor Yes No High The infusion

pump motor is Press the key to
Error
operating stop infusion and turn
abnormally. off the alarm. Press the

key to restart
infusion. If this alarm
sounds again, please
contact the
manufacturer.

Drop rate Yes No High There is an Reset the drop rate

error error with the parameters correctly.
(requires drop rate
an optional parameter
drop rate settings.
sensor) Accuracy is Recalibrate tube
not calibrated. accuracy.
Running the Shake the water
pump for long droplets off the funnel
periods of time walls.
results in water
droplets
forming on the
funnel walls,
affecting the
monitoring
capabilities of
the drop rate
sensor.
Liquid is not Eliminate blockage in
able to flow the infusion circuit.
freely within
the tube.
There is a fault Contact the
with the drop manufacturer.
rate sensor.
40 drops of Check if the tube is
liquid are leaking.
detected when
the pump is
stopped.

C-3
 Alarm Information display A B L Cause Action required

Parameter Yes Yes High In Time Mode Reset parameters and

Error and BW Mode, ensure that rate is
calculated rate within the allowable
exceeds range.
0.1–2000 ml/h.

Low Yes No Mid-level Low battery. Connect an AC power

battery source and recharge
the battery.
The battery is Contact the
old or there is manufacturer.
a fault with the
charging circuit
of the infusion
pump.
Reminder Yes No Mid-level The infusion The infusion pump was
pump was not started within the set
started within time period after the
the set time correct installation of
period after the the tube.See 'Methods
correct for setting starting
installation of times' 5.2.6 Reminder
the tube. Settings

Handle Yes Yes Mid-level Handle open

during Press to stop
Open
infusion. infusion and turn off the
alarm. Close the
handle and press

to restart
infusion.

Not connected
AC The AC indicator light Connected to AC
No No Low to AC power
Disconnect does not illuminate. power source.
source.

C.2 Prompt Messages

None

C-4
D Symbols and Terms
D.1 List of Units

Abbreviation English Chinese

min minute 分钟

h hour 小时

Hz hertz 赫兹

mg milligrams 毫克

g gram 克

kg kilogram 千克

kPa kilopascal 千帕

ml milliliter 毫升

D-1
D.2 List of Terms

Abbreviation English meaning Chinese meaning

AC Alternating current 交流电

DC Direct current 直流电

EMC Electromagnetic compatibility 电磁兼容性

KVO Keep vein open 保持静脉通畅流速

ERROR Error 错误的，出错

LED Light emitting diode 发光二极管

SN Serial Number Serial number

EtO C2H4O (Ethylene Oxide) 环氧乙烷

Bolus (Discrete quantity of liquid 短时间内输送液体的离散量

BOLUS
delivered in a short time) （即快进）

D-2
P/N: 046-004735-01(2.0)